UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000041257
Receipt number R000047102
Scientific Title The Relation of Breast-feeding and Eating Behavior from 9-month-olds to 47-month-olds children.
Date of disclosure of the study information 2020/08/01
Last modified on 2021/08/10 16:53:41

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information

Public title

The Relation of Breast-feeding and Eating Behavior from 9-month-olds to 47-month-olds children.

Acronym

The Relation of Breast-feeding and Eating Behavior in toddlers and young children.

Scientific Title

The Relation of Breast-feeding and Eating Behavior from 9-month-olds to 47-month-olds children.

Scientific Title:Acronym

The Relation of Breast-feeding and Eating Behavior in toddlers and young children.

Region

Japan


Condition

Condition

None (Healthy children)

Classification by specialty

Not applicable Child

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

1. To Clarify the percentage of a breast-feeding and eating behavior in children who are weaning or already had weaned.
2. To find some factors that a breast-feeding style is affected eating behavior.

Basic objectives2

Others

Basic objectives -Others

To consider the suitable usage of a bottle and nipple in infants and toddlers, and the transition from breast-feeding to weaning.

Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

We will conduct the online survey that hear from mothers about their children's feeding condition and style, eating condition or something.

Key secondary outcomes



Base

Study type

Others,meta-analysis etc


Study design

Basic design


Randomization


Randomization unit


Blinding


Control


Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms


Purpose of intervention


Type of intervention


Interventions/Control_1


Interventions/Control_2


Interventions/Control_3


Interventions/Control_4


Interventions/Control_5


Interventions/Control_6


Interventions/Control_7


Interventions/Control_8


Interventions/Control_9


Interventions/Control_10



Eligibility

Age-lower limit

9 months-old <=

Age-upper limit

47 months-old >=

Gender

Male and Female

Key inclusion criteria

1. Children who are breast-feeding, bottle-feeding, mixed, or already weaning.
2. Children who eat solid food including baby food from their mouth.
3. Mothers who agree to join our online survey.

Key exclusion criteria

1. Children who are delay to motor development.
2. Children who are only breast-milk or artificial milk.(ever have not eaten baby food or solid food)
3. Children who are tube feeding.

Target sample size

900


Research contact person

Name of lead principal investigator

1st name Sumiko
Middle name
Last name Kuroishi

Organization

Pigeon Corporation

Division name

Research and Development DIV. Breast-feeding Lab.

Zip code

300-2495

Address

6-20-4, Kinunodai, Tsukubamirai-shi, Ibaraki 300-2495, Japan

TEL

0297-52-6532

Email

sumiko.kuroishi@pigeon.com


Public contact

Name of contact person

1st name Yoshimi
Middle name
Last name Osugi

Organization

Pigeon Corporation

Division name

Research and Development DIV. Breast-feeding Lab.

Zip code

300-2495

Address

6-20-4, Kinunodai, Tsukubamirai-shi, Ibaraki 300-2495, Japan

TEL

0297-52-6532

Homepage URL


Email

yoshimi.oosugi@pigeon.com


Sponsor or person

Institute

Pigeon Corporation, and Macromill, Inc.

Institute

Department

Personal name



Funding Source

Organization

Pigeon Corporation

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization



Other related organizations

Co-sponsor

Macromill, Inc.

Name of secondary funder(s)



IRB Contact (For public release)

Organization

Ueno-Asagao Clinic Ethical Review Committee

Address

6F Kairaku Building 2-7-5 Higashiueno Taito-ku Tokyo 110-0015, JAPAN

Tel

03-6240-1162

Email

jimukyoku@tes-h.co.jp


Secondary IDs

Secondary IDs

NO

Study ID_1


Org. issuing International ID_1


Study ID_2


Org. issuing International ID_2


IND to MHLW



Institutions

Institutions

株式会社マクロミル(東京都)/ Macromill, Inc. (Tokyo)


Other administrative information

Date of disclosure of the study information

2020 Year 08 Month 01 Day


Related information

URL releasing protocol

-

Publication of results

Published


Result

URL related to results and publications

https://www.jschild.med-all.net/Contents/private/cx3child/2021/0080s1/219/0196-0196.pdf

Number of participants that the trial has enrolled

764

Results

The continuation of breastfeeding or bottle-feeding should affect on the amount of eating, how to eat, and the usage of tableware compared to children who already finished breastfeeding. For example, breast-feeding and bottle-fed children tended to have an unbalanced diet, small meals, and a low proportion of eating by themselves with their hands or spoon.

Results date posted

2021 Year 08 Month 10 Day

Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics

Number of valid answers; n=512
Some answers were deleted as below reasons; inadequate answers, children who were delayed in motor development, or children who have eaten baby food in first stage only or have never eaten baby food.

Participant flow

The cross tabulation analysis were conducted by the situation of feeding based on the age.

Adverse events

None

Outcome measures

If the cell were under 30 numbers, these data were analyzed as reference information.

Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Main results already published

Date of protocol fixation

2019 Year 12 Month 20 Day

Date of IRB

2019 Year 12 Month 23 Day

Anticipated trial start date

2020 Year 01 Month 17 Day

Last follow-up date

2020 Year 02 Month 04 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

None


Management information

Registered date

2020 Year 07 Month 30 Day

Last modified on

2021 Year 08 Month 10 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047102


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name